NIKO

Primary DI
00853512006974
Brand
NIKO
Company
NIKOMED USA
Model
8200
Catalog number
8200
Device description
THERMAL RELECTORS - LARGE
Published
2025-12-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KGXTape And Bandage, Adhesive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KGXTape And Bandage, AdhesiveGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20853512006978PackageGS15In Commercial Distribution
10853512006971PrimaryGS10
00853512006974Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2085351200697820853512006978
1085351200697110853512006971
00853512006974008535120069748535120069740853512006974

GMDN Terms#

Term, Definition table
TermDefinition
Infant heat shieldA protective guard intended to be used to reduce heat loss due to insensible water loss, i.e., evaporation, during the radiant warming of primarily premature infants. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)355-6456info@nikomedusa.com

Regulatory Flags#

DUNS number
073648341
Device count
100
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10850078465006NIKOTRACE704270422026-08-17
10850078465013NIKOTRACE705070502026-08-17
10850078465020NIKOTRACE706070602026-08-17
10853512006995NIKOTRACE652065202026-01-23
00853512006998NIKOTRACE652065202026-01-23
10853512006971NIKO820082002025-12-09
10853512006988NIKO810081002025-12-09
00853512006981NIKO810081002025-12-09
10853512006940EMEEME3015-5SEME3015-5S2025-11-11
20853512006947EMEEME3015-5SEME3015-5S2025-11-11
10853512006957NIKOTRACE304030402025-08-08
10853512006964NIKOTRACE4039-44039-42025-08-08
20853512006954NIKOTRACE304030402025-08-08
20853512006961NIKOTRACE4039-44039-42025-08-08
10853512006513NikoSurg2407-N2407-N2018-10-05
10853512006575NikoSurg240824082018-01-17
30853512006517NikoSurg2407-N2407-N2018-10-05
20853512006572NikoSurg240824082018-01-17
10853512006810NIKOTRACE301430142025-03-21
10853512006827NIKOTRACE301530152025-03-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00050428344095CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDKGX2026-10-16
20665973032423DukalDukal LLCKGX2026-10-14
20665973032430DukalDukal LLCKGX2026-10-14
00050428142677CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDKGX2026-10-10
00050428143124CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDKGX2026-10-10
00050428340523CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDKGX2026-10-10
00050428340936CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDKGX2026-10-10
00050428341308CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDKGX2026-10-10
00050428342053CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDKGX2026-10-10
00050428342121CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDKGX2026-10-10
00050428342602CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDKGX2026-10-10
00050428346396CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDKGX2026-10-10
00050428347133CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDKGX2026-10-10
00389152744957Adhesive Sleeve, 10 Pack, Tandem MobiTandem Diabetes Care, Inc.KGX2026-10-07
00389152745459Adhesive Sleeve, 2 Pack, Tandem MobiTandem Diabetes Care, Inc.KGX2026-10-07
00197998029844Solventum™ Micropore™Solventum Germany GmbHKGX2026-10-05
00311917088556WalgreensWALGREEN CO.KGX2026-09-30
08859922800036EquateWAL-MART STORES, INC.KGX2026-09-30
08859922800043EquateWAL-MART STORES, INC.KGX2026-09-30
08859922800050EquateWAL-MART STORES, INC.KGX2026-09-30
08859922800067EquateWAL-MART STORES, INC.KGX2026-09-30
00850087488877CeeportCEEPORT INC.KGX2026-09-29
00197998095641Transpore™Solventum US LLCKGX2026-09-25
00197998095672Transpore™Solventum US LLCKGX2026-09-25
00197998095702Transpore™Solventum US LLCKGX2026-09-25
00197998095733Transpore™Solventum US LLCKGX2026-09-25
00197998095788Transpore™Solventum US LLCKGX2026-09-25
00197998103612Transpore™Solventum US LLCKGX2026-09-25
00197998103636Transpore™Solventum US LLCKGX2026-09-25
00197998164118Transpore™Solventum US LLCKGX2026-09-25